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PHARMALEXREGULATORY AFFAIRS · UZBEKISTAN

Medicine registrationNew medicines, generics and biologics: from dossier to certificate.
Medical device registrationDevices of every risk class: technical file, testing, expert review.
Medical equipment registrationEquipment for clinics and laboratories, including service documents.
Re-registrationWe renew the registration before the certificate expires.
VariationsA new manufacturer, pack, composition or patient leaflet.
Dietary supplement registrationImport and production permit, sanitary-epidemiological conclusion.

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PHARMALEXREGULATORY AFFAIRS · UZBEKISTAN

Pharmalex registers medicines, medical devices and equipment, and dietary supplements in Uzbekistan for foreign manufacturers and importers.

PHARMALEX Private Enterprise7a/31 Yangi Olmazor Street, Almazar District, Tashkent 100000, Uzbekistan+998 94 050 66 88 info@pharmalex.uz

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Medicine registration Medical device registration Medical equipment registration Re-registration Variations Dietary supplement registration

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All documents Medicines Medical devices and equipment Dietary supplements Cosmetics Sports nutrition

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All documents159 Registration and dossier30 Quality, GxP and pharmacopoeia22 Safety and post-marketing control8 Clinical trials4 Licensing and supervision6 Circulation, import and labelling44 Controlled substances15 Prices, procurement and reimbursement10 Framework and sector reforms20

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Found: 36

Latest documents

Order of the Minister of Health · No. 5 · 2 March 2026Checked against the official sourceAdditions to the list of orphan medicines for rare diseases and medical devices for diagnosis and treatment of rare diseasesMedical devices and equipmentMedicines
Order of the Minister of Health · No. 6 · 28 July 2025Checked against the official sourceAmendments to the list of medicines and devices allowed for use and import without state registration subject to mandatory certificationMedical devices and equipmentMedicines
Order of the Minister of Health · No. 9 · 27 June 2025Checked against the official sourceAdditions to the list of orphan medicines for rare diseases and medical devices for rare diseasesMedicinesMedical devices and equipment
Order of the Minister of Health · No. 5 · 27 February 2025Checked against the official sourceList of medicines and medical equipment allowed for use and import without state registration subject to mandatory certification and lacking registered analoguesMedical devices and equipmentMedicines
Cabinet of Ministers Resolution · No. 564 · 12 September 2024Checked against the official sourceList of measuring instrument groups of state significance; separation of verification and state metrological controlMedical devices and equipment
Order of the Minister of Health · No. 34 · 21 August 2023Checked against the official sourceList of essential medicinesMedicines

All documents by section

Registration and dossier10 docs

Presidential Resolution · No. PP-238 · 24 June 2026Improving prevention, early detection and treatment of cancer
Order of the Minister of Health · No. 7 · 30 April 2026Requirements for medicinal-product state-registration documents
Pharmaceutical Safety Center guidelineGuidance on medicinal-product application assessment
InstructionMedical-device registration-document requirements — Center source
Pharmaceutical Safety Center guidelineGuidance on expert assessment of registration documents
Pharmaceutical Safety Center guidelineGood Review Practice guidance — GrevP
Pharmaceutical Safety Center guidelineGuidance on package leaflets and summaries of product characteristics
OrderMedicine and medical-device registration fees — Center source
Pharmaceutical Safety Center guidelineGuidance on suspension and cancellation of registration certificates
Pharmaceutical Safety Center guidelineGuidance on variations to medicinal-product registration documents

Quality, GxP and pharmacopoeia7 docs

Cabinet of Ministers Resolution · No. 43 · 30 January 2021On approval of the lists of products subject to mandatory conformity confirmation
Cabinet of Ministers Resolution · No. 472 · 7 September 2026On additional measures to improve legislation on technical regulation
Cabinet of Ministers Resolution · No. 554 · 2 September 2025On amendments to certain Government decisions to simplify conformity assessment procedures
Cabinet of Ministers Resolution · No. 502 · 14 August 2024On approval of regulations on product state registration and conformity assessment procedures
State standardNational Good Clinical Practice standard — Center source
State standardNational Good Distribution Practice standard — Center source
State standardNational Good Manufacturing Practice standard — Center source

Licensing and supervision2 docs

Cabinet of Ministers Resolution · No. 86 · 22 February 2022On the Unified Regulation on issuing certain permits through a special electronic system
Cabinet of Ministers Resolution · No. 577 · 19 October 2026On introducing a system that grants medical and pharmaceutical workers the right to practise through state registration

Circulation, import and labelling6 docs

Order of the Minister of Health · No. 122 · 8 June 2020Approval of orphan medicines for rare diseases and the list of medical equipment for rare diseases
Order of the Minister of Health · No. 15 · 30 April 2026Amendments to certain departmental acts of the Ministry of Health (medical device terminology)
Presidential Resolution · No. PP-295 · 4 October 2025Additional measures for accelerated industrial development in the regions and export promotion
Presidential Resolution · No. PP-393 · 12 October 2022On supplying the population with quality international-brand products and integrating domestic firms into global value chains
Law of the Republic of Uzbekistan · No. 221-I · 26 April 1996On protection of consumer rights
State standardGood Pharmacy Practice — GPP

Controlled substances2 docs

Cabinet of Ministers Resolution · No. 713 · 10 November 2025Amendment to Annex 37 to the Unified Regulation on licensing via the special electronic system (Resolution No. 80 of 21.02.2022)
Cabinet of Ministers Resolution · No. 818 · 27 September 2019On regulating the turnover of potent substances

Prices, procurement and reimbursement1 docs

Order of the Minister of Health · No. 18 · 23 April 2026List of diseases included in the reimbursement programme and medicines provided for their treatment

Framework and sector reforms2 docs

Presidential Resolution · No. PP-178 · 12 May 2026On organizing the work of the Food Safety Committee
Presidential Decree · No. UP-36 · 16 February 2024On additional measures to ensure food security

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